JP4722122B2 - Second wire device and mounting procedure - Google Patents

Abstract

This invention relates generally to a second wire apparatus and its installation in the PTCA (percutaneous transluminal coronary angioplasty) process. More specifically, this invention relates to construction of the distal end of the second wire apparatus and a system for guiding it down an earlier installed guide wire to assist in balloon angioplasty in vessels with proximal tortuosity or as a more substantial guide wire for atherectomy devices, stents, lasers or other medical catheter devices. The second guide wire apparatus allows for use of stiffer wire, reduces or eliminates twisting and coiling about the first guide wire, and permits the second guide wire to be fed rapidly down the first guide wire. The second guide wire apparatus can be fed all the way to the distal end of the first guide wire and then released from the first guide wire so that the first guide wire can be removed or advanced to the next stenosis if so desired. The second guide wire apparatus is sufficiently longer than the first guide wire so that the distal ends of the guide wires may be disengaged from each other at the point where the proximal ends of the guide wires are equidistant from entering the body or are disposed adjacent to each other.

Description

(Related application)
This patent document contains 35 USC § of provisional US patent application 60 / 554,048 filed March 17, 2004 and provisional US patent application 60 / 633,749 filed December 7, 2004. 119 (e) Claim the benefit of the filing date under. All of the above applications are hereby incorporated by reference into the present disclosure.

In general, the present invention relates to a second wire device and its attachment in the process of PTCA (percutaneous transluminal coronary angioplasty) . More particularly, the present invention relates to the configuration of the distal end of the second wire device and the artery in the blood vessel with the proximal bend that guides it under the previously attached guidewire. It relates to a system that assists in forming balloons or provides a more rigid guide wire for atherectomy devices, stents, stent delivery devices, lasers or other medical catheter devices.

Traditionally, balloon angioplasty in a blood vessel that is meandering to the proximal side is associated with frequent severe complications and surgical failures due to the inability of the guidewire to move through the lesion or poor guide catheter support. was there. Low profile style balloons, supportive hydrophilic support guidewires, and geometric guide catheters have improved PTCA results in these and other difficult lesions. When the proximal side is tortuous, all atherectomy devices, stents, stent delivery devices, lasers, and other medical catheter devices are bulky, flexible and traceable compared to typical balloon catheters. If it is low, it becomes a problem.

Most guidewires have a lubricious coating to enhance the movement of the guide wire, typically, a diameter of 0.036 cm (0.014 inches). For winding vessels, a conventional 0.014 cm (0.014 inch) supple guidewire may be sufficient, but in situations where the tip of the guidewire escapes from the target lesion, a tapered core guide It is better to use a wire. In some cases, steering and tip responses are lost when the guidewire passes through multiple bends or stenosis in the blood vessel. One option with limited success is to install a more rigid tip guidewire to improve handling. Another option in the field of the present invention is to add a special support guidewire with a more rigid shaft rather than a tip to straighten the vessel curvature and facilitate guidewire movement. is there.

Durable guidewires are not generally suitable as initial use guidewires due to their rigidity and low torque controllability, but they have a strong support force even when other guidewires fail, Improve traceability of balloons, stents, stent delivery devices, atherectomy devices and other medical catheters. However, supplying a first guide wire and parallel to the guide wire of this second stiffness is consuming procedure cumbersome and time, the second guide wire spiral or coiled around the first guide wire It becomes, as a result, unintentional movement occurs in the first guide wire, or may have to be re-fed pull out the second guidewire. Moreover, if it is necessary Unplug pull the second guide, may guide wire is contaminated, there may be necessary to restart the entire process using the components of the sterile. The time spent on this process can be critical to the success of the procedure.

One object of the present invention is to provide a second guidewire device and mounting procedure, wherein the mounting means uses a rigid wire and reduces or eliminates twisting and wrapping around the first guidewire. And allows the second guidewire to be rapidly delivered (in line) under the first guidewire (in the body). The second purpose is delivered over the distal end of the first guidewire and then, if desired, the first guidewire can be removed or advanced to the next constriction. It is to provide a second guidewire device that can be released from the wire.

The third purpose is to provide a second guidewire device that is sufficiently longer than the first guidewire (in the body) when the proximal ends of both guidewires are equidistant from where they entered the body. Or when both guidewires are placed adjacent to each other, allowing the distal ends to disengage from each other. This allows expensive and time-consuming radiofluoroscopy to be used to determine when the first guidewire and the second guidewire have disengaged from each other, or the distal end of the guidewire or its A radiopaque marker placed in the vicinity eliminates the need to monitor the position of each distal end.

For a fuller understanding of the present invention , reference will now be made, by way of example, to the following description in conjunction with the accompanying drawings.

FIG. 1 shows an embodiment of a second guidewire device 10 according to the present invention that engages a mounted first guidewire 12. The attached first guidewire 12 is inserted into the blood vessel of a patient (not shown) in a standard manner and advanced until its distal end 20 passes over the lesion or stenosis (not shown) to be treated. The second guidewire device 10 is shown as engaging the first guidewire and approaching its distal end 20.

FIG. 2 is a cross-sectional view of FIG. 1 showing the assembly of the end effector slide 16, also referred to as a coupling element, to the distal end portion of the second support wire 14. In one embodiment, the end effector slide 16 is fixedly attached or connected to the distal end of the second support wire 14 so as to form a unitary structure. As will be described in more detail later, the end effector slide 16 includes a guidewire channel or passage 32 (see FIG. 4 ) so that it can be mounted until it has passed through a lesion or stenosis (not shown) . One guide wire 12 can be engaged and pushed along the first guide wire 12.

FIG. 3 is a top view of one embodiment of an end effector slide 16 according to the present invention. End effector slide 16, also referred to as a connecting element, includes a proximal (or intermediate) opening 34 that provides access to the proximal end of guidewire channel 32 (FIG. 4). The end effector slide 16 is approximately 25 mm (1 inch) in length and 0.9 mm (0.035 inch) in diameter. As best seen in FIG. 2, the proximal opening 34 is configured so that the mounted first guidewire 12 is at a relatively closed angle relative to the central axis of the end effector slide 16. , Thereby minimizing the overall profile of the combined second guidewire device 10 and the attached first guidewire 12. Proximal opening 34 is approximately 10 mm from the distal end of end effector slide 16. However, in any of these components , there are various sizes and sizes depending on the size of the second support wire 14, the size of the attached first guide wire 12, and the medical procedure in which these guide wires are utilized. It should be understood that configurations can be utilized. In the preferred embodiment shown, the end effector slide 16 is made of polytetrafluoroethylene (PTFE) and has a low friction hydrophilic coating at its distal end, but is lubricious. It can be made from other materials such as any number of high temperature thermoplastics having an outer surface. FIG. 3 also shows chamfers 26, 22 at the proximal and distal ends of end effector slide 16, respectively. These chamfers 22 and 26 make it difficult to damage the vessel wall as the end effector slide 16 travels in both directions through the lesion or stenosis, or turns around a tortuous bend in the blood vessel.

In the illustrated embodiment, the end effector slide 16 further includes a radiopaque marker 24 at or near the distal end and a second radiopaque at or near the trailing edge of the proximal opening 34 . It comprises a marker 18 and a third radiopaque marker 28 at or near the proximal end. Radiopaque markers 24, 18, 28 allow the precise position of the end effector slide 16 relative to the distal end 20 of the first guidewire 12 within the vessel to be treated to be monitored by fluoroscopy. it can. As will be described below , it may be important to monitor the position of the guidewire in order to determine when the guidewire has engaged or disengaged within the blood vessel. In the illustrated embodiment, the radiopaque markers 24, 18, 28 comprise a gold-plated surface that is attached to the outer surface of the end effector slide 16. However, any number of standard radiopaque marker constructs well known to those skilled in the art can be modified.

As a modification to the inclusion or use of radiopaque markers, the second wire guide device 10 may have an overall length comparable to the length of the attached first guide wire 12. More specifically, by way of example only, the second wire guide device 10 may comprise a second support wire 14 having a length approximately equal to the length of the attached first guide wire 12. As will be described below, when the lengths of these guidewire components are approximately equal, the user can compare the relative positions of the proximal ends of the guidewires so that the end effector slide 16 is mounted. It can be determined when the disengagement has passed through the distal end 20 of the first guidewire 12 that has been made. In other words, the end effector slide 16 is mounted when the proximal end of the second guidewire device 10 and the proximal end of the mounted first guidewire 12 project equidistantly from the patient's body. and it will be detached from the distal end portion 20 of the first guide wire 12.

FIG. 4 is a cross-sectional view of the end effector slide (engagement element) 16 showing the guidewire channel (passage) 32 extending through the distal portion. The guidewire channel 32, a first guide wire 12 which is mounted to slide along it engages (FIG. 2) is configured and dimensioned. In the illustrated embodiment, the guide wire channel 32 is typically have a circular cross section slidably receiving through the wire guide diameter 0.036 cm (0.014 inches). For example, the guidewire channel 32 may have an inner diameter of 0.043 cm (0.017 inch). Guidewire channel 32 extends between a proximal opening 34 that provides access to its proximal end and a distal opening 30 that provides access to its distal end. In the illustrated embodiment, guidewire channel 32 has a length of approximately 10 mm, although other lengths may be utilized. The end effector slide 16 is preferably configured to withstand excessive bending along its length, particularly at or near the proximal (or intermediate) opening 34. Such a configuration prevents buckling of the first guide wire 12 when the second guide wire device 10 is pushed along the first guide wire 12 attached.

The end effector slide 16 is further configured to be fixedly engaged with the distal end of the second support wire 14 (FIG. 2) to form a unitary structure or assembly. Part or insertion channel 38. The connecting portion of the insertion channel 38 and the second support wire 14 is configured to resist excessive bending, and when the second guide wire device 10 is pushed along the attached first guide wire 12 Furthermore, it is preferable not to bend. The distal end of the second support wire 14 can be attached to or joined to the end effector slide 16 by any number of ways known to those skilled in the art.

5, the outer as well as aligned with the proximal end portion 36 of the first guide wire 12, the distal end of the end effector slide 16 to the proximal end 36 of the first guide wire 12 which is mounted attached The 2nd guide wire apparatus 10 in the predetermined position which inserts and starts sliding is shown. More particularly, the distal opening 30 of the end effector slide 16 is configured so that when the second guidewire device 10 moves further distally with respect to the attached first guidewire 12 , the proximal end 36. Is aligned with the proximal end 36 of the attached first guidewire 12 so that it enters the guidewire channel 32 .

FIG. 6 shows the proximal end of the second support wire 14 along the attached first guidewire 12 until the end effector slide 16 passes over the distal end 20 of the attached first guidewire 12. It shows a state in which the portion is pushed by applying a pressing force to the portion, whereby the two guide wires can be disengaged from each other and separated. In one exemplary PTCA process will exceed through the lesion distal end of both the guide wire is treated.

In the embodiment shown in FIG. 6, the second support wire 14 projects approximately 15 mm ( 0.58 inch) axially into the central portion of the end effector slide 16. The second support wire 14 is typically 0.44 mm (0.014 inch) in diameter , but may be any diameter selected to optimize the procedure, and the end effector slide The outer diameter of 16 can increase at the same rate . The second support wire 14 has a rigidity that is generally greater than the rigidity of the first mounting guide wire 12. In the preferred embodiment, the second support wire 14 is manufactured from Nitinol, but for many applications other materials such as stainless steel are sufficient. The second support wire 14 may be lubricated with silicone, PTFE or the like to facilitate movement through the blood vessel. The second support wire 14 may also have an outer surface color selected to contrast with the attached first guide wire 12 to help the user distinguish between the two guide wires. Good.

The operation of the second guide wire device 10 will be described below. A first guide wire 12 is inserted into a blood vessel using standard PTCA method, the distal end portion 20 is steered in a conventional controller to a sufficiently past the lesion or stenosis to be treated. Subsequently, as shown in FIG. 5, the attached first guide wire 12 is held in a stationary state by a conventional over-the-wire method, and the end portion of the second guide wire device 10 to which the second support wire 14 is attached. The effector slide 16 is slid out of the proximal end 36 of the attached first guide wire 12. The end effector slide 16 along a first guide wire 12, so as to pass over the lesion or stenosis to be treated, pushes distally the second support wire 14, the first guide wire 12 attached . As shown in FIG. 6, to the end effector slide 16, by being pushed out of the distal end portion 20 of the first guide wire 12 which is mounted, the two guide wires are separated to release the engagement to one another The second support wire 14 is further pushed in the distal direction with respect to the attached first guide wire 12. The separation of the two guide wires can be monitored by X-ray fluoroscopy if the end effector slide 16 is equipped with a radiopaque marker, or if the guide wire is the same length, It may be determined by comparing the relative positions of the proximal ends. At this point, while two guide wires are parallel to each other in the vessel, the first guide wire 12 can be further advanced to the next lesion or stenosis to be treated along the vessel, and the step It may be repeated, or the first guidewire 12 may be withdrawn with the more rigid second support wire 14 clamped . The second support wire 14, angioplasty balloons, stents, stent delivery device, rotating atherectomy devices, medical catheter device, or other bulky, become the guide wire, such as for more flexibility and trackability low device be able to.

  Accordingly, the foregoing detailed description is considered to be illustrative rather than limiting, and is intended to define the spirit and scope of the invention, including all equivalents, in the claims. It will be understood that there is.

FIG. 6 is a top view of a second guidewire device engaged with a first guidewire. FIG. 6 is a cross-sectional view of a second guidewire device engaged with a first guidewire. FIG. 6 is a top view of an end effector slide. It is a cross-sectional view of an end effector slide. FIG. 10 is a top view of a second guidewire device in an initial or starting position ready to engage the proximal end of a mounted first guidewire. Moved in a distal direction past the distal end of the first guide wire is attached, it is a cross-sectional view of the second guide wire apparatus which has been separated by disengaging from the first guide wire.

Claims (11)

A guide for guiding an elongated medical device into a mammal's body,
One wire guide comprising a proximal portion and a distal portion;
A coupling element fixedly integrated with the distal portion of the one wire guide, the coupling element comprising a distal end, a proximal end, and a passageway; The passage extends between a distal opening at a distal end of a coupling element and an intermediate opening positioned between the distal and proximal ends of the coupling element; The passage is configured to slidably engage another wire guide ;
The connecting element and the one wire guide are coaxial,
The connecting member is configured not to bend at a position along its length,
The guide, wherein the one wire guide and connecting element is movably disposed through a wire guide lumen of a medical catheter to guide the medical catheter into a mammalian body . Having the other wire guide slidably passed through the passage of the connecting member;
The guide according to claim 1, wherein the one wire guide has a rigidity greater than that of the other wire guide. Having the other wire guide slidably passed through the passage of the connecting member;
The guide of claim 1, wherein the one wire guide has a diameter greater than that of the other wire guide. The guide according to claim 1, wherein the coupling element comprises an insertion channel fixedly attached to the distal end of the wire guide at the proximal end of the coupling element .   The guide according to claim 1, wherein the intermediate opening is arranged on a side surface of the connecting element.   The guide of claim 1, wherein the connecting element comprises a radiopaque marker.   The guide of claim 6, wherein the radiopaque marker is disposed near a distal end of the connecting member.   The guide according to claim 7, wherein the connecting member further comprises a second radiopaque marker disposed near its intermediate opening. The guide according to claim 1, wherein the connecting member has a diameter larger than a diameter of the one wire guide.   The guide according to claim 9, wherein the connecting member comprises a bevel at one of its proximal and distal ends. The guide according to claim 1, wherein the connecting member has a rigidity greater than that of the one wire guide.

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